Sosei Group Corporation: QVA149 Filed as a Once-Daily Maintenance Treatment for COPD in Europe

TOKYO, October 25, 2012 /PRNewswire/ –

Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information
released today by Novartis that QVA149, (indacaterol maleate / glycopyrronium bromide) an
investigational drug for chronic obstructive pulmonary disease (COPD) has been filed for
marketing authorisation with the European Medicines Agency (EMA), triggering a $5 million
milestone payment to Sosei.

The first five studies in the Phase III IGNITE clinical trial program for QVA149
formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective
superiority primary endpoints of FEV1 area under the curve (AUC) for 0-12 hours at 26
weeks versus salmeterol/fluticasone, mean trough FEV1 at 26 weeks versus both indacaterol
maleate and glycopyrronium bromide, reduction in the rate of exacerbations versus
glycopyrronium bromide, and exercise endurance time at 21 days versus placebo. The data
from ENLIGHTEN demonstrated that QVA149 has a similar overall adverse event profile to
placebo.

CEO of Sosei, Shinichi Tamura commented:

“We are delighted with the EU filing for QVA149.

The IGNITE program is among the largest COPD clinical trials performed, the results
from which provide strong support as to the effectiveness and safety of QVA149 and its
potential to treat patients suffering from this progressive disease. Today’s news follows
the recent approval of Seebri(R) Breezhaler(R)in Europeand Canada, and Seebri(R)
Inhalation Capsulesin Japan.”

Notes for editors

About QVA149:

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of
indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for the
maintenance treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is
one of the largest international clinical trial programs in COPD comprising 10 studies in
total with more than 7,000 patients across 42 countries[1]-[13]. The first five studies
(ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already completed in 2012 with three
additional studies (BLAZE, ARISE, BEACON) expected to complete by the end of the year. The
studies are designed to investigate efficacy, safety and tolerability, lung function,
exercise endurance, exacerbations, breathlessness and quality of life. Further filings for
regulatory approval are expected in Q4 2012 for Japan and at the end of 2014 for the US.

All Novartis inhaled COPD portfolio products are being developed for delivery via the
Breezhaler(R) device, a single-dose dry powder inhaler (SDDPI), which has low air flow
resistance, making it suitable for patients with airflow limitation, such as COPD
patients. The Breezhaler(R) device allows patients to hear, feel and see that they have
taken the drug correctly[1].

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or
occupational exposure, which can cause obstruction of airflow in the lungs resulting in
debilitating bouts of breathlessness. It affects an estimated 210 million people
worldwide[14] and is predicted to be the third leading cause of death by 2020[15].
Although COPD is often thought of as a disease of the elderly, 50% of patients are
estimated to be within the ages of 50 and 65, which means that half of the COPD population
are likely to be impacted at the peak of their earning power and family responsibilities[
16].

About Sosei

Sosei is an international biopharmaceutical company anchored in Japan with a global
reach. It practises a reduced risk business model by acquiring compounds from, and
bringing compounds into, Japan through exploitation of its unique position within global
markets.

For further information about Sosei, please visit http://www.sosei.com.

Forward-looking statements

This press release contains forward-looking statements, including statements about the
discovery, development and commercialisation of products. Various risks may cause Sosei’s
actual results to differ materially from those expressed or implied by the forward-looking
statements, including: adverse results in clinical development programmes; failure to
obtain patent protection for inventions; commercial limitations imposed by patents owned
or controlled by third parties; dependence upon strategic alliance partners to develop and
commercialise products and services; difficulties or delays in obtaining regulatory
approvals to market products and services resulting from development efforts; the
requirement for substantial funding to conduct research and development and to expand
commercialisation activities; and product initiatives by competitors. As a result of these
factors, prospective investors are cautioned not to rely on any forward-looking
statements. We disclaim any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information, future events or
otherwise.

References

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http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001114/human_med_001219.jsp&mid=WC0b01ac058001d124

          . Last Accessed 12 September 2012.
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SOURCE Sosei Group Corporation